Senior Clinical Research Associate, Cell & Gene Therapy
District of Columbia
Full Time
2 days ago
No Visa Sponsorship
Key skills
Google Cloud PlatformGCPGoogle CloudCommunication
About this role
Role Overview
Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs
Conduct on-site and remote monitoring to ensure protocol adherence
Maintain essential documentation and keep site and patient data inspection-ready
Build strong relationships with sponsors and sites
Serve as a key point of contact throughout the study
Support development of study-specific procedures (e.g., Monitoring Plans)
Assist in training or coordinating other CRAs
Requirements
Bachelor’s degree (life sciences, nursing, or related field preferred)
5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience)
Senior CRA levelling: SCRA I (3–5 yrs) – independently manages complex sites; SCRA II (5+ yrs) – oversees complex sites/regions, mentors peers, and drives process improvements
Broad therapeutic exposure across multiple study types and indications
Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols
Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines
Excellent written and verbal communication; confident stakeholder engagement
Solid understanding of medical/therapeutic areas and medical terminology
Proven ability to train, coach, and mentor clinical research staff
Proficient with MS Office and EDC systems; willing to travel up to 80%
Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate
Tech Stack
Google Cloud Platform
Benefits
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance